What is CTD - common technical document?
The agreement to assemble all the Quality, Safety and Efficacy information in a common format (called CTD - Common Technical Document ) has revolutionised the regulatory review processes, led to harmonised electronic submission that, in turn, enabled implementation of good review practices.
What are the clinical summaries in Module 2 of the CTD?
There are two high level clinical summaries in Module 2 of the CTD: the Clinical Overview, a short document that provides a critical assessment of the clinical data; and the Clinical Summary, a longer document that focuses on data summarisation and integration.
How many modules are in a CTD?
The CTD is organised into five modules. Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions. In July 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the strongly recommended format of choice for NDAs submitted to FDA, United States.
What is a review and revision of the CTD?
The document proposes a review and revision in some parts of the Section 2.5 Clinical Overview of the Module 2 of the Common Technical Document (CTD) (Section 2.5.1 and 2.5.6) to ensure the guideline is both Harmonised and sensible in its entirety.
Droit Institutionnel de lUnion européenne
Droit constitutionnel de l’Union européenne
Bien comprendre les 5 composantes de l'intelligence émotionnelle
Les émotions1
L'essentiel du droit international public
Module 4 – Personnel aide
Modules 1 à 8 DEAS
Referentiel de formation du diplome professionnel d'aide soignant
Étape 1
